Compliance 101: An Overview of Health Care Compliance and Integrity Programs Nina W. Tarnuzzer, MHA,CPA,CPC Assistant Dean, Physician Billing Compliance University of Florida, College of Medicine Monday, November 7, 2011

Helpful Disclosure Warning: These printed materials are not designed to include all points that will be presented in class or include information helpful to know for purposes of testing. 9/16/2018

Presentation Summary Compliance as a Profession Fundamental programmatic elements Commitment, culture and organization Core elements of a program Key Challenges A rapidly changing environment Regulatory hot buttons What are the rules, anyway? Compliance as a Profession 9/16/2018

Why is Compliance a Hot Topic? Largest $$$ Federal Programs Largest $$$ State Programs Large organizations, large scale fraud and abuse Recoveries ($$Enforcement/$$ Recovery) Ratio is Excellent Recoveries in BILLIONS of dollars 9/16/2018

In just three years, the Medicare and Medicaid programs will account for 50 percent of all national health spending. Medicare's Hospital Insurance (HI) Trust Fund is expected to pay out more in hospital benefits and other expenditures this year than it receives in taxes and other dedicated revenues.  In addition, the Medicare Supplementary Medical Insurance (SMI) Trust Fund that pays for physician services and the prescription drug benefit will continue to require general revenue financing and charges on beneficiaries that will grow substantially faster than the economy and beneficiary incomes over time. National Coalition on Health Care 9/16/2018

National Health Care Spending National health spending is expected to reach $2.5 trillion in 2009, accounting for 17.6 percent of the gross domestic product (GDP). By 2018, national health care expenditures are expected to reach $4.4 trillion—more than double 2007 spending.1 National health expenditures are expected to increase faster than the growth in GDP: between 2008 and 2018, the average increase in national health expenditures is expected to be 6.2 percent per year, while the GDP is expected to increase only 4.1 percent per year.   9/16/2018

Simple Version of Compliance Identify RISK Explain the RISK to your organization Identify PROBLEMS FIX PROBLEMS REPEAT 9/16/2018

Compliance is usually perceived as dry and boring Until… …something goes wrong Refunding, legal bills, damage to reputation, potential criminal charges are not boring, but not where you want to be 9/16/2018

Simple Version – Federal view The federal government is no longer going to “pay and chase” errors. Providers are responsible for accurate and honest requests for payment, and are expected to get it right. Do not expect to submit a bill to the federal government and the government have the burden of determining if it appropriate to pay. There will be serious consequences for both careless and intentional claims for services to which the recipient is not entitled. 9/16/2018

“An early Christmas gift from our compliance officer… a bloodhound trained to sniff out non-compliant providers.”

Data on insurance premium costs The average employer-sponsored premium for a family of four costs close to $13,400 a year, and the employee foots about 27 percent of this cost.4  Health insurance costs are the fastest growing expense for employers.  Employer health insurance costs overtook profits in 2008, and the gap grows steadily Employees have seen their share of job-based coverage increase at nearly the same rate during this period jumping from $1,543 to $3,515. 9/16/2018

Fundamentally, an ethics and compliance program has two purposes: to ensure that all individuals in an organization observe pertinent laws and regulations in their work; and to articulate a broader set of aspirational ethical standards that are well-understood within the organization and become a practical guideline for organization members making decisions that raise ethical concerns. Alan Yuspeh, JD, Sr VP Ethics, Compliance and Corporate Responsibility 9/16/2018

Must have the active support of senior management ) Must have the active support of senior management Is fundamentally about corporate culture- instilling the commitment to observe the law, and more generally, do the right thing Operating management are committed to the success of the compliance program (the compliance office can’t do it for them.) The ethics and compliance effort should be about the conduct of individu Alan Yuspeh, JD, Sr VP Ethics, Compliance and Corporate Responsibility 9/16/2018

Key Challenges We function in a highly complex, rapidly changing environment Number of rules and laws more complex and technical, number of rules increasing Substantial fines and enforcement actions, negative publicity Legal requirements vs. Ethical responsibility Following the law isn’t good enough 9/16/2018

Perspective One - A Contract Compliance with Federal and State legal requirements If you accept federal or state money, you must conduct your business according to their standards Protecting Private information Key target for identity theft Confusion and error in the victim’s medical record as diagnoses for other people’s conditions are added. 9/16/2018

Beyond what’s in the contract… What are the “Rules”? Laws and regulations Industry standards “Best” and “Sound” practices Ethical norms Where do you set the bar? 9/16/2018

Challenges: Business Perception of Compliance Requirements not designed by physicians, many times not consistent with delivery of quality care Cost of compliance program – Time requirements Some rules just not very clear 9/16/2018

Compliance Officer’s Job Description JD, MBA, MHA and/or CPA Progressive levels of experience in the field Communication skills – speaking and writing Diplomatic/People skills Strong sense of core values Thick skin Must report “high” in the organizational structure 9/16/2018

Diplomatic skills are important 9/16/2018

Current Areas Physician Billing Hospital Billing Privacy Clinical Trials and Research Conflict of Interest Employment (Sarbanes-Oxley) DME Enforcement Agencies Consultants 9/16/2018

Difference between Criminal and Tort Law Fraud – is knowingly and willfully executing or attempting to execute, a scheme or artifice to defraud any health care benefit program or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of any health care benefit program. Mens rea - the “mental element” 9/16/2018

Difference between Criminal and Tort Law Abuse may directly or indirectly, result in unnecessary costs to the Medicare or Medicaid program, improper payment, or payment for services which fail to meet professionally recognized standards of care, or that are medically unnecessary. Abuse involved payment for items or services when there is no legal entitlement to that payment and the provider has not knowingly and/or intentionally misrepresented facts to obtain payment. 9/16/2018

The US Sentencing Commission- FEDERAL ENFORCEMENT AND THE FALSE CLAIMS ACT- and Qui Tam lawsuits (whistleblowers) The US Sentencing Commission- Created by Congress in 1984, its purpose is to draft narrow parameters for determining criminal sentencing. The original intent was to standardize criminal penalties. There are now specific guidelines for violations of Healthcare law, that help define the Federal Government’s expectations. 9/16/2018

A compliance program built to accomplish its mission: To Deter The Program Mission A compliance program built to accomplish its mission: To Deter To Detect To Address the issues promptly 9/16/2018

7 Common Elements in Compliance Guidelines Implement written policies, procedures, and standards of conduct Designating a compliance officer and a compliance committee Conducting effective training and education IMPORTANT 9/16/2018

7 Common Elements in Compliance Guidelines Developing effective lines of communication Enforcing standards through well publicized disciplinary guidelines Conducting internal audits and monitoring IMPORTANT 9/16/2018

7 Common Elements in Compliance Guidelines Responding promptly to detected offenses and developing corrective action. IMPORTANT 9/16/2018

“You can’t reduce the paper work, so here is a periscope to see over it.”

Federal Guidelines Tip: “guidelines” is a misnomer. The federal government makes these guidelines mandatory – even in voluntary programs. (DRA 2005) 9/16/2018

Center for Medicare and Medicaid Services (CMS) A Federal Priority Center for Medicare and Medicaid Services (CMS) Office of the Attorney General FBI Office of Inspector General The Legislature has passed strong enabling legislation including the Balanced Budget Act and HIPAA 9/16/2018

A Federal Apparatus is now in place Billions are recovered – Qui Tam relators 85% of case load From the substantial settlements – the programs move toward becoming self-funding State Medicaid programs have their own False Claims rules Over 38,000 persons have been excluded from participation 9/16/2018

Government Programs with Active Enforcement STATE MEDICAID Programs MEDICARE – Part A – Hospitals and Nursing Homes Part B - Physician Services Part D - Prescription Drugs Durable Medical Equipment 9/16/2018

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It’s important for everyone to know the rules THE STANDARD The severity of the punishment or settlement comes down to what the organization KNOWN or SHOULD HAVE KNOWN when it submitted false or fraudulent claims. 9/16/2018

Penalties for non-compliance Reimbursement (pay what you owe back), Civil penalties and interest They can suspend your billing until you go out of business Exclusion of you as an individual from any company doing business with the Federal government Exclusion of institution from participation in Medicare and Medicaid Criminal charges – you can go to jail 9/16/2018

“May I suggest a compliance program?”

Trends – Sophisticated Analysis and Monitoring Data mining – matching data from different types of service (i.e., physician compared to hospital) Recovery Audit Contractors Private companies that are paid based on a percentage of recovery (bounty hunters) 9/16/2018

Pfizer Settlement - 2009 Already under a CIA Largest health fraud settlement in US history Most extensive CIA ever imposed Whistleblower was John Kopchinski – a former sales rep $2.3 billion settlement Criminal fine of $1.195 billion Promotion of Bextra for several uses and dosages that FDA specifically declined to approve due to safety concerns. Bextra, Geodon, Zyvox, and Lyrica 9/16/2018

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May 20, 2009 FERA - Fraud Enforcement and Recovery Act of 2009 Introduced by Senators Patrick Leahy (D-VT), Ted Kaufman (D-DE) and Chuck Grassley (R-IA) HEAT – Health Care Fraud Prevention and Enforcement Action Team Attorney General , Eric H. Holder, Jr. and Health and Human Services (HHS) Secretary, Kathleen Sebelius, announced the new and aggressive inter-agency task force. 9/16/2018

FERA Made it a violation of the False Claims Act to knowingly and improperly retain government money if there is an obligation to return the money. The health reform bill states that “an overpayment must be reported and returned” within 60 days of the date the provider “knows of the overpayment”. Draft of America’s Affordable Health Choice Act defines a Medicare or Medicaid overpayment” as “any finally determined funds that a person receives or retains … …to which the person , after applicable reconciliation, is not entitled.” Providers not off hook for civil or criminal sanctions if fraud involved 9/16/2018

Watch America’s Affordable Health Choices Act of 2009 1,000 page bill (H.R. 3200) devotes 55 pages to program integrity and fraud-fighting measures Integrity plans will be a requirement for participation Already required under the Deficit Reduction Act of 2005 for many providers (>$5 million) Spells out the required elements including a hotline, auditing and monitoring, procedures to return overpayments Failure invites civil penalties or disenrollment 9/16/2018

Case states that Compliance role must be both proactive and reactive Proactive efforts need to emphasize the complimentary goals of prevention and corporate ethical behavior. Reactive efforts measure how well a corporation reacts when it learns that questionable and potentially illegal corporate conduct has occurred - United States v. Caputo Case states that Compliance role must be both proactive and reactive 9/16/2018

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Questions? 9/16/2018